Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea (APNiA)

September 5, 2018 updated by: Joaquin Duran-Cantolla, MD, Hospital Universitario Araba

Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea

To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP), performed at home compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA).

METHODOLOGY: DESIGN: Randomized, prospective, multicenter, and crossover trial. The study will include 240 adults, both sexes, with clinical suspicion of obstructive sleep apnea (OSA). MEASUREMENTS: To all patients with clinical suspected OSA and referred to the sleep units, the following questionnaires and measurements will be performed: a) clinical history; b) Anthropometric variables: weight, height, body mass index, neck circumference and percentile; c)Epworth sleepiness scale; OSA questionnaire, quality of life and clinical questionnaires and comorbidity; d) PSG in the sleep laboratory; e) HRP at home; f) Cost-effectiveness variables.

ANALYSIS: Data from HRP and from full PSG will be compared as follows: 1) Agreement of results according to the different apnea-hypopnea index by using the Receiver Operating Characteristic (ROC) curve; 2) The concordance of the diagnosis and treatment decisions when using clinical findings and data from PSG or HRP at home; 3) All data will be analyzed independently; 4) A cost-effectiveness analysis of the different diagnostic and therapeutic procedures will be performed.

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Araba
      • Gasteiz / Vitoria, Araba, Spain, 01009
        • Hospital Universitario Araba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women over 18 years to 75 years old, with clinical suspicion of OSA
  • Written informed consent signed

Exclusion Criteria:

  • Psycho-Physical inability to perform the study at home
  • Presence of insomnia or depressive syndrome
  • Patient with malformation syndromes, Down syndrome and neuromuscular diseases
  • Cardiovascular, cerebrovascular or respiratory disease exacerbated.
  • Previous Positive continuous pressure (CPAP ) treatment or surgery for OSA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diagnostic Randomizing
Randomizing to start with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)
Other: Standard Polysomnography (PSG)
Randomizing to start with Standard Polysomnography (PSG)
Other Names:
  • Validity
Other: Standard Polysomnography (PSG)
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Other Names:
  • Effectiveness
Other: Home Respiratory Polygraphy (APNIA)
Randomizing to start with home respiratory polygraphy (APNIA)
Other Names:
  • Validity
Other: Home Respiratory Polygraphy (APNIA)
Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA)
Other Names:
  • Effectiveness
Active Comparator: Therapeutic Randomizing
Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)
Other: Standard Polysomnography (PSG)
Randomizing to start with Standard Polysomnography (PSG)
Other Names:
  • Validity
Other: Standard Polysomnography (PSG)
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Other Names:
  • Effectiveness
Other: Home Respiratory Polygraphy (APNIA)
Randomizing to start with home respiratory polygraphy (APNIA)
Other Names:
  • Validity
Other: Home Respiratory Polygraphy (APNIA)
Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA)
Other Names:
  • Effectiveness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index (AHI)
Time Frame: baseline
To assess the diagnostic validity of a home respiratory polygraphy (HRP) compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA), based on the results of the Apnea-hypopnea Index (AHI).
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale
Time Frame: baseline and at 6 month
The Epworth Sleepiness Scale (the sum of 8 items score,0-3) can range from 0 to 24. Scores of 11-24 represent increasing levels of excessive daytime sleepiness.
baseline and at 6 month
Blood pressure
Time Frame: baseline and at 6 month
Blood pressure measurements: systolic blood pressure and diastolic blood pressure
baseline and at 6 month
Anthropometric variables (Body mass index)
Time Frame: baseline and at 6 month
Body mass index
baseline and at 6 month
Quality of life (EuroQOL test)
Time Frame: baseline and at 6 month
Evaluate by EuroQOL test, is a standardised measure of health status. Description of the state of health in five dimensions (mobility, self-car, usual activities, pain/discomfort and anxiety/depression), each o wich is defined with three levels of severity, as measured by a Likert scale type (no problems, some problems and many problems or inability to activity).
baseline and at 6 month
Therapeutic decision
Time Frame: 6 month
The concordance of the diagnosis and treatment decision when using clinical findings and data from standard polysomnography (PSG) or home respiratory polygraphy (HRP).
6 month
STOP-BANG Sleep apnea questionnaire
Time Frame: baseline and at 6 month
Sleep Apnea Questionnaire. High STOP-Bang score indicates a high probability of obstructive sleep apnea.
baseline and at 6 month
Berlin questionnaire
Time Frame: baseline and at 6 month

The questionnaire consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories.

High Risk:

if there are 2 or more categories where the score is positive.

Low Risk:

if there is only 1 or no categories where the score is positive.
baseline and at 6 month
Cost-effectiveness analysis
Time Frame: 6 month
Cost-efficacy evaluation
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Araba

Collaborators

BTI Biotechnology Institute S.L
Instituto de Investigación Sanitaria BIO-ARABA

Investigators

  • Study Director: Joaquin Duran-Cantolla, Hospital Universitario Araba
  • Principal Investigator: Eduardo Anitua-Aldecoa, BTI Technology Institute SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

September 30, 2016

First Submitted That Met QC Criteria

January 23, 2018

First Posted (Actual)

January 30, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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